A Phase 4 interventional study of Ondansetron and Placebo in Nausea and Vomiting, Postoperative, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-01-31.
Sponsored by Hospital for Special Surgery, New York · Phase 4, Interventional, and Treatment
The study is a randomized placebo controlled trial to determine whether repeated postoperative prophylactic ondansetron ("Zofran") administration will prevent postoperative and/or postdischarge nausea and vomiting in patients undergoing ambulatory hip arthroscopy. Ondansetron will be administered in the intra- and post-operative period. These individuals will be followed on postoperative days 1, 2, and 3. It is hypothesized that the incidence of postdischarge nausea and vomiting (PDNV) will be significantly decreased by postoperative prophylactic administration of multiple doses of ondansetron (Zofran).
629 studies on the registry are indexed under Postoperative Nausea and Vomiting; 113 are open to participants now.
This study's enrollment of 98 is below the median of 111 across 525 interventional studies indexed under Postoperative Nausea and Vomiting.
Browse Postoperative Nausea and Vomiting studies →Hospital for Special Surgery, New York is the lead sponsor of 226 studies on the registry; 40 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 22 (73%) have results posted.
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The study group will receive intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
Drug: Ondansetron
The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
Drug: Placebo
The study group will receive 4 mg of IV ondansetron perioperatively and also postoperative oral ondansetron tablets (8 mg each day for two days). The tablets will be concealed in generic capsules prepared by the pharmacy at the Hospital for Special Surgery to make the ondansetron tablets indistinguishable from the placebos.
Also known as: Zofran
The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days). These placebo tablets will contain lactose and be indistinguishable from the study medication.
Incidence of Nausea
Percentage of participants with nausea
Time frame: Postdischarge Day 1
Severity of Nausea
Percentage of participants reporting moderate or severe nausea in the first 24 hours
Time frame: Postdischarge Day 1
Impact of Nausea and Vomiting on Quality of Life
Percentage of participants whose quality of life was impacted by nausea and vomiting
Time frame: Postdischarge Day 1
| Milestone | Study Group | Control Group |
|---|---|---|
| Started | 49 | 49 |
| Completed | 39 | 37 |
| Not completed | 10 | 12 |
Percentage of participants with nausea
| percentage of participants | Study Group | Control Group |
|---|---|---|
| Incidence of Nausea | 46 | 54 |
Percentage of participants reporting moderate or severe nausea in the first 24 hours
| percentage of participants | Study Group | Control Group |
|---|---|---|
| Severity of Nausea | 23 | 32 |
Percentage of participants whose quality of life was impacted by nausea and vomiting
| percentage of participants | Study Group | Control Group |
|---|---|---|
| Impact of Nausea and Vomiting on Quality of Life | 18 | 30 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study Group | — | 0/49 (0%) | 0/49 (0%) |
| Control Group | — | 0/49 (0%) | 0/49 (0%) |
| Age Continuous(years) | Study Group | Control Group | Total |
|---|---|---|---|
| Mean | 42 ± 14 | 37 ± 11 | 39 ± 13 |
| Sex: Female, Male(Participants) | Study Group | Control Group | Total |
|---|---|---|---|
| Female | 18 | 19 | 37 |
| Male | 21 | 18 | 39 |
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ondansetron
Postoperative Nausea and Vomiting →
Hospital for Special Surgery, New York →